President and Managing Partner
Peter Latham has twenty years in general management and thirteen years in financial, strategic and business development consulting to the biotech industry. As founder and president of New Venture Advisors, Inc., then BioPharm Services, Inc. (which became Latham BioPharm Group), Mr. Latham has worked with a variety of companies ranging from large pharmaceutical companies to biotechs, venture capitalists and start-up entities. He has served as Acting President and on a variety of boards for clients ranging from start-ups to publicly traded companies. Prior to this, Mr. Latham was V.P. Engineering and Licensing for Drug Delivery Development, Inc. (DDD) where he managed the US operations and negotiated several large licenses for a drug delivery firm based in France. Prior to DDD, Mr. Latham was Subsystem Manager at McDonnell Douglas responsible for all of the cargo handling systems and interiors on the USAF C-17 program.
Mr. Latham holds a B.S. in Mechanical Engineering from Rensselaer Polytechnic Institute, an M.S. in Management from Massachusetts Institute of Technology’s Sloan School, and is a certified Program Manager (PgMP) with the PMI.
Michael McGinnis has over twenty years of international business development, strategic planning, marketing, program management and general management experience in the Pharmaceutical and Biotechnology industries. He has senior level experience in both the commercial and government sectors, and a strong track record of achieving organizational growth targets. Most recently, as Director of New Business for DynPort Vaccine Company (DVC – a reputable biodefense product development organization within the Fortune 200 company CSC), Mr. McGinnis was responsible for leading the company’s new business activities and functions in the US Government sector. He was actively engaged with client organizations including CBMS, DTRA, BARDA and NIAID and teaming partners, i.e. CROs, Pharma/Biotech, and CMOs. As part of this role, Mr. McGinnis was responsible for all aspects of new business, including providing strategic oversight of both technical and budgetary aspects of proposals in response to US Government medical countermeasure advanced development program solicitations. Prior to joining DVC, he worked at ICON Clinical Research, as Executive Director of Sales, and at MedTrials, Inc. as the Associate Director of Business Development & Marketing, and held various leadership roles with global business development and marketing responsibilities for the CROs in the Biopharmaceutical, Pharma and Medical Device industries.
Mr. McGinnis earned a B.S. in Business Administration from Towson University, an M.B.A. from Loyola University Maryland, and an M.S. in Biotechnology from Johns Hopkins University.
Joshua Speidel, Ph.D.
Dr. Speidel leads Government Services helping our clients identify, win and execute on government grants and contracts. He formerly lead the development and execution Product Development Management, Strategic Consulting, and Medical Device / Diagnostic Development sector offerings at LBG providing subject matter expertise and advisory services on pharmaceutical product development, mergers and acquisition, strategic business development, and due diligence to clients. Dr. Speidel is a biotechnology product development professional with experience from pre-discovery through lifecycle management of mature products destined for the HHS Pandemic Influenza Vaccine Stockpile. Dr. Speidel provides technical expertise, program management and federal contract compliance support to clients. He has led teams in the submission of proposals resulting in $400M of awards. As a Health Scientist for the U.S. Department of Health and Human Services (HHS), Biomedical Research and Development Authority (BARDA), he led efforts to establish the core capabilities to support the licensure of medical countermeasures in the areas of manufacturing capacity, product development, clinical studies, and long-term stockpiling. At BARDA, Dr. Speidel was responsible for the post-licensure management of three pandemic influenza vaccine stockpile programs, one advanced development program for a licensed recombinant influenza vaccine, and the Clinical Studies Network program. The total contract values of these efforts were in excess of $17 billion. Earlier, while consulting to the U.S. Defense Advanced Research Projects Agency (DARPA), Dr. Speidel created programmatic concepts that were pitched to DARPA’s director and resulted in excess of $250M in contract awards, was the technical point of contact for two teams in the “Accelerated Manufacturing of Pharmaceuticals” program which pioneered efforts in recombinant vaccine production, and was the project manager for their $100M response to the H1N1 pandemic that built three tobacco based manufacturing facilities and advanced a pre-discovery stage vaccine candidate through a Phase 1 Clinical Trial, on time and on budget.
Dr. Speidel received a Ph.D. in Physiology and Biophysics from Cornell University, a M.Sc. in Biochemistry and Biophysics from the University of Houston and a B.S. in Biochemistry and Molecular Biology from Pennsylvania State University.
Mr. Newton has over thirty years of experience in the design and management of technical development programs often working directly with government agencies. He has managed the design, build and validation of specialized pharmaceutical automation systems and instruments and the development of advanced concepts for manufacturing of pharmaceuticals. In his last position, Mr. Newton was Division Manager at Foster Miller, now QinetiQ North America, where in addition to building the business segment, he managed the early stage development of a technology for manufacturing drug products in a miniaturized system for battlefield applications. Prior to Foster Miller, Mr. Newton was Director of Thermal Technologies for OHM Remediation Services where he was responsible for the design, installation and validation of chemical process systems under the EPA Superfund program . In these capacities and at Latham BioPharm Group, Mr. Newton has won and managed projects working with the U.S. Navy, Army Corps of Engineers and DARPA.
Mr. Newton holds both a B.S. and an M.S. in Mechanical Engineering from Tufts University and is an active member of ISPE, PMI, and ALA.
Georgia Sloboda has over 30+ years of experience in the biotechnology/pharmaceutical industry with emphasis in the vaccines and oncology space. Georgia’s background includes experience in Quality Operations, Quality Systems and Compliance, Board of Health Inspection management, Manufacturing Operations/Tech Transfer, CMO oversight and Regulatory Compliance. As the Senior Director of Global Quality Systems for Celgene, Georgia was responsible for implementing best in class solutions across the GxP’s for Document Management, Risk Management, Deviations Management, Complaint management and Laboratory Management. During her tenor, she was responsible for developing the global roadmap and portfolio of best in class systems for the organization. With the acquisition of Celgene in 2019, Georgia led the Quality organization as the GMP lead for the Integration program with Bristol Myers-Squibb.
Prior to that role, Georgia served as the Site Head of Audits and Compliance for Pfizer. In that role, Georgia led the compliance organization for the site to manage best in class processes for Inspection management and audit readiness, Quality Governance Council, Specification limits and review team, global supplier management and organizational management across the network. The team was also successful in leading the PAI efforts for the oncology business for Pfizer, a first in class facility that is licensed to manufacture Mylotarg®. In addition, Georgia served as a Quality lead for the Hospira/Pfizer integration. As the Director of Quality Assurance, Georgia was responsible for Quality oversight for drug substance and formulation of Pfizer’s next generation pneumococcal conjugate vaccine, Prevnar 13®. Georgia’s experience includes product development oversight, analytical method approval, validation, supplier management, contract laboratory oversight, manufacturing, stability, specifications, and commercialization. Georgia has in depth experience working with key suppliers, contract laboratories, CMO’s and closed system and sterile filling technologies.
Georgia has a B.S. in Business Administration and an MBA in Finance and Marketing from St. Thomas Aquinas College. Georgia is active with the PDA Metro Chapter and has presented on topics related to Compliance and Auditing.
Timothy Alcorn, Ph.D.
Director, Medical Devices and Diagnostics
Dr. Timothy Alcorn is an experienced clinical chemist and molecular biologist with more than 25 years of experience in the healthcare industry. Throughout his career he has worked in a variety of healthcare sectors including reference laboratories, medical device manufacturing, medical software development, in vitro device development, and pharmaceutical development. He has extensive experience in infectious diseases having been the laboratory director at LabCorp’s Center for Molecular Biology and Pathology where he developed advanced clinical assays and ran a laboratory that generated over $50 million in revenue. In addition, he was Director of Clinical Affairs at Janssen Diagnostic Inc. where he helped bring new diagnostics and software to the global market to support the launch of drugs for the treatment of HIV and HCV. Dr. Alcorn has also overseen the development and global commercialization of medical devices including a handheld ultrasound device and wearable sensors for monitoring ECG and patient vitals. Dr. Alcorn served on the scientific advisory board for Roche Diagnostics for several years as well as other diagnostic companies. In addition, he has authored numerous publications, book chapters, and international clinical chemistry guidelines. Over the years Dr. Alcorn has also gained significant experience in global reimbursement, health economics, and commercialization. Additionally, Dr. Alcorn has experience in device and diagnostic regulations and is currently an adjunct professor at the Johns Hopkins University’s graduate regulatory science department where he teaches courses in IVD regulation and translational biotechnology.
Dr. Alcorn is a HIPAA Privacy and Security Expert and served as the privacy officer for a health medical records system. Dr. Alcorn started his career at the University of North Carolina working on sexually transmitted diseases pathobiology and vaccine development.
Robert P Casillas, Ph.D., Fellow ATS
Director, Nonclinical Consulting
Dr. Casillas is a business strategic professional and biochemical toxicologist with over 25 years’ nonclinical development experience identifying workable solutions for novel products in the Medical Countermeasures (MCM) and Companion Animal Health markets. This includes 20 years’ managing CRO chem/bio containment and preclinical facilities, along with over 350 staff. He provides a proven customer focus and value creation for Global clients, with demonstrated success in establishing strategic partnerships and cross-functional teams to develop new revenue streams and drive growth. Dr. Casillas formerly served as VP, Strategic Global Health Security (MRIGlobal); VP, CBRN Business Integration (Battelle); and VP, Biomedical S&T (Battelle), where he established strategic and tactical plans to facilitate awards of over $900M in multi-year contracts with government, industry, and academia. He has worked with government funded small/large Pharma, virtual Biotech, and Academia, the top small/large Global Animal Health companies, the DoD (i.e., DTRA, JPEO, DARPA), DHHS (i.e., BARDA, NIH, FDA, CDC), and DoE to develop national defense, public/animal health MCMs. He has overseen or consulted on 100’s of nonclinical projects for non-GLP and pivotal IND/NDA-enabling GLP studies (primarily FDA Animal Rule applications), target animal safety studies, toxicant and/or drug delivery, and formulation/device feasibility. He played a management/program/scientific role for eight EUA or FDA licensed medical CBRN defense products. Dr. Casillas is also a Colonel in the U.S. Army Reserve and serves as a CBRN medical defense SME for senior leaders.
Dr. Casillas is on the Board of the Missouri Biotechnology Association, KSU-Olathe, KU-Edwards, and recently on the Kansas City Animal Health Corridor Board. He is an Adjunct Professor in the Dept of Pharm/Tox, Rutgers University, and a Fellow of the Academy of Toxicological Sciences.
Dr. Casillas received his Ph.D. in Biochemistry and B.S. in Microbiology from Georgia State University and was a Post-Doctoral Fellow in the Department of Biochemistry, Center in Molecular Toxicology, at Vanderbilt University SOM.
Joseph Rininger, Ph.D.
Director, Cell and Gene Therapy
Dr. Rininger possesses over eighteen years of experience in basic biomedical research and biopharmaceutical product development program management with an emphasis on vaccines, adjuvants and gene therapy. As the Senior Director, Influenza at Protein Sciences Corporation (PSC), Dr. Rininger was the program manager of a BARDA contract for the advanced development and commercialization of Flublok®, the first approved recombinant hemagglutinin-based subunit vaccine for influenza. This encompassed planning and leading a cross-functional team in the execution of tasks involving all areas of recombinant vaccine development (process development, formulation development and stability, pre-clinical efficacy and toxicology, quality control/quality systems, process and facility validation, manufacturing process transfer, regulatory affairs and clinical development).
Prior to that role, he served as Director of Business Development and worked to secure new CMO programs, grew an established research product business unit evaluated in- and out-licensing of technology and performed writing and submission of NIH grant funding opportunities. He has solid skills in international business development, strategy and alliance management; working with CMOs, CROs, medical device company sterile filling technology, For the CMO projects PSC, he successfully oversaw project teams for the development of upstream and downstream processes for transfer to cGMP manufacturing of four vaccine candidates and two biologics. He also has experience in product development and program management of rAAV-based gene therapies and had a supportive regulatory role in the approval of Glybera, the first gene therapy to attain marketing approval. He has also supported three rAAV development programs for orphan diseases and authored the CMC section for a program that has entered human clinical trials.
Dr. Rininger earned a Ph.D. from Cornell University in Toxicology and a B.S. in Marine Biology with a Concentration in Biotechnology from Fairleigh Dickinson University. He has several awarded and pending patents and is well published in industry magazines and peer-reviewed journals.
Director, Strategic Consulting
Mr. Orlowski leads LBG’s Strategic Consulting services helping Global Life Science Clients across LBG’s Practice areas with strategic advisory including Commercialization, Market Access, M&A/Divestitures, Buy-Side/Sell-Side Due Diligence, and Organization Optimization.
As a Retired Pfizer Executive, Mr. Orlowski worked for over 25 years in positions of increased responsibility in Finance, Strategy, & Operations. Frank lead the Supply Chain & Finance functions across Asia, Eastern Europe, South America, & The Middle East, developing business, operational & financial market access product localization strategies. He had direct financial control of a $2 Billion Yearly Operating Plan, managing a team of over 300 in-country finance colleagues across 35 Global Markets. In an Entrepreneurial-Type Role at Pfizer, building new markets from the ground-up, Frank consistently demonstrated expertise to work in multi-cultural environments in over 35 countries partnering with influential in-country organizations & governments in complex negotiations to localize manufacturing production & commercialization of over 10,000 product SKU’s to help exceed Pfizer’s global growth targets. Frank was Pfizer’s most important China Market Expert, growing it to the First Billion Dollar Revenue Pharma Country outside the US & Europe. Through Pfizer’s acquisitions of Warner-Lambert, Pharmacia, King, Wyeth & Hospira, Frank was an Integration Leader designing & implementing combined organizational, financial processes & systems across all functions in new global shared services. Including successful & sustainable organization & cost optimization strategies. As a Due Diligence Expert in Manufacturing for Pfizer, Frank also lead over 45 market-specific acquisition/JV Initiatives, partnering with in-country financial institutions, family offices, and governments, to develop combined revenue-generating strategies
Mr. Orlowski currently sits on The Board of The American Cancer Society, where he advises for their new Philanthropic Impact Fund, Bright Edge. Mr. Orlowski received an MBA in International Finance from NYU Stern School of Business and a BS in Accounting from Providence College
Thijs Beuming, Ph.D.
Dr. Thijs Beuming leads the In Silico Drug Discovery Services at LBG. Dr. Beuming has more than 15 years of experience applying computational biophysics, computational chemistry, bioinformatics and cheminformatics to problems in biology and drug discovery, in academia and industry.
Prior to joining LBG, Dr. Beuming spent over a decade at Schrödinger, Inc, the global leader in providing computational chemistry and molecular modeling solutions to the biopharmaceutical and materials industries. Dr. Beuming had a leading role in the Application Science department at Schrödinger, where he managed project and customer support to clients in the NY, NJ and PA region. He has supervised technology implementations in a variety of fields, including ligand and structure based small molecule discovery, and biologics research. He also made extensive contributions to Schrödinger’s in house drug discovery projects, in his role as Research Leader in the Drug Discovery Applications Group.
Dr. Beuming has made key contributions to novel methodologies to key problems in computational chemistry, including the study of protein flexibility, protein solvation, thermodynamic binding affinity calculations, and small molecule and peptide docking. His work has been documented in over 50 peer-reviewed articles and reviews.
Dr. Beuming holds a Masters degree in Medicinal Chemistry from the Vrije Universiteit in Amsterdam, the Netherlands. He obtained his Ph.D. in Physiology and Biophysics from Weill Medical College at Cornell University, where he focused on elucidating structure function studies of neurotransmitter transporters. He serves as adjunct professor of Computational Biomedicine at Weill Medical College at Cornell University.
Robert Huebner, Ph.D.
Dr. Robert Huebner is an experienced biotechnology program manager with over twenty-five years of research experience with viral and microbiological pathogens and expertise in the vaccine industry, group management, and program management. Throughout his career, he has worked for a variety of organizations, large pharma companies, government agencies, and a contract research organization, holding positions of increasing responsibility at each. Most recently, while working at the Biomedical Research and Development Authority (BARDA) of the Department of Health and Human Services, Dr. Huebner held several positions including Acting Director of the Influenza Division, Deputy Director and Chief of Universal Influenza Vaccine Development. While serving as Acting Director, he was responsible for over 50 programs valued in excess of $5 billion, highlighted by the licensure of three new types of influenza vaccines, and approval of a new near patient diagnostic platform for influenza and RSV. Prior to BARDA, at the Midwest Research Institute, now MRIGlobal, Dr. Huebner grew the client base for the biotechnology section he managed, bringing in awards from: the Department of Homeland Security for pathogen sensor development; the FDA’s Center for Food Safety and Applied Nutrition for pathogen detection in food; DynPort Vaccine Corporation (DVC) for assessment of vaccines in animal models; and other industrial clients for aerosol sciences studies. Dr. Huebner started his career as a bench scientist and group leader at Connaught Laboratories, now Sanofi Pasteur, working on applied research to develop new and improved vaccines against Lyme disease, influenza, Dengue, Japanese Encephalitis, malaria and pneumococcal disease.
Dr. Huebner received a Ph.D. in Molecular Biology and Microbiology from Tufts University in Boston, MA and a B.S. in Biology from Carnegie Mellon University, Pittsburgh, PA.
Gretchen Stup brings more than twenty years of experience in the management of government contracts, and over twenty-two total years of experience working in a scientific environment to Latham BioPharm Group. At LBG, she serves as a Principal Consultant where she provides program management and systems integration support to government and client-related projects for companies of different sizes. She is a certified Project Management Professional (PMP) and much of her experience lies in total project lifecycle management. Ms. Stup has successfully managed multiple government contracts, including Plague, Tularemia, Ebola, and Anthrax vaccine development projects. She supported the development of Vaccinia Immune Globulin (VIGIV), which was one of the first FDA-licensed biodefense products. Besides her in-depth experience in the management of government (including Prime) contracts, she has been involved in the management and oversight of various subcontracting organizations, ranging from small R&D facilities to large, complex CMOs and CROs. Ms. Stup has experience with the Animal Rule and has supported FDA filings and negotiations through product licensure. Prior to working in Program Management at LBG and previously at DynPort Vaccine Company (DVC), she co-developed and implemented DVC’s comprehensive Risk Management Program, and worked as a Quality Assurance specialist at Boston Biomedica, Inc. (now Pressure BioSciences, Inc.).
Ms. Stup earned a Bachelor of Science degree from Shepherd University and is a Project Management Professional (PMP) as certified by the Project Management Institute.
Principal Consultant, Product Development
Patrick Falvey has over 30 years of research, managerial and technical experience in the Pharmaceutical and Biotechnology Industries. He has enjoyed various positions of responsibility and leadership in Operations, Quality Assurance, and Compliance and believes in collaboration among individuals and groups to effect positive change and improvement.
Patrick has previously been a Senior Team Lead for Pfizer with responsibility for the manufacture of Prevnar 13 vaccine, (prevention of pneumococcal meningitis) one of the world’s most successful vaccines. He has hosted and responded to various agency audits including FDA, EMA, SFDA (China) and was responsible for overall Department Inspection Readiness program. He has led and been responsible for a team of Investigation and Compliance specialists that closed hundreds of investigations and commitments to maintain state of compliance. He has onboarded & designed GMP training programs for new college graduates for introduction to Aseptic & Cleaning Qualification programs to support multiple aseptic manufacturing lines and has managed site GMP Training/Safety programs. Patrick has worked with a variety of companies ranging from large pharmaceutical companies to start-up ventures.
Patrick received his Bachelor of Science in Biochemistry from University College Cork in Ireland, Masters of Science (Industrial Pharmacy) from Long Island University in Brooklyn, and his Master of Business Administration from Iona College in New Rochelle NY.
Allen Duplantier, Ph.D.
Principal Consultant, Product Development
Dr. Duplantier is a medicinal chemist with 20 years of industry and 8 years of government experience in drug discovery and development. He has worked in all stages of early drug development including hit-to-lead, lead optimization, candidate selection and IND submission. He was a Laboratory Supervisor and Design Lead at Pfizer in the therapeutic areas of neuroscience, inflammation, allergy, and respiratory diseases, and had leadership roles on a variety of multi-disciplinary project teams. These efforts led to the delivery of four clinical drug candidates giving him the opportunity to be part of several clinical candidate development teams. Dr. Duplantier spent 2 years as a Senior Advisor at DTRA where he managed the discovery and development of medical countermeasures (MCMs) to chemical weapons, was personally responsible for a $32M per year portfolio of projects, and lead a team to stand up an ADME center for the DoD. More recently, as a contractor at USAMRIID he has had leadership roles in the identification and optimization of therapeutics for the treatment of viral and bacterial infections, and toxin poisoning. He was a key contributor to USAMRIID’s recent COVID-19 outbreak and 2014 EBOV outbreak responses to rapidly assess, evaluate, and prioritize externally partnered therapeutics. He is an Adjunct Lecturer for Johns Hopkins University’s Advanced Academic Programs. He has published over 60 research articles, book chapters, and patent applications.
Dr. Duplantier received a Ph.D. in Organic Chemistry from the Massachusetts Institute of Technology, and a B.S. in Chemistry from the University of New Orleans.
Principal Consultant, Product Development
Anushri Singhvi is an experienced professional and entrepreneur with over 20+ years of experience in research and development in the pharmaceutical and biotechnology industry supporting product development, portfolio, program and alliance management in both private and public sectors.
Anushri’s professional career began at Merck & Co., Inc., where she started as a scientist in analytical development and later moved into project management and integration. In her role as a project manager at Merck, Anushri supported the development and licensure of the human papilloma virus (HPV) vaccine (Gardasil®). At PATH, Anushri was responsible for managing several public-private partnerships in vaccine development for a number of diarrheal diseases. At MedImmune (now Astra Zeneca), Anushri supported the product development teams for early-stage vaccine candidates as well as the infectious disease innovative medicines (iMED) therapeutic area.
Anushri co-founded Serenta Biotechnology, a company focused on developing a vaccine against staphaloccocus aureus. At Serenta, Anushri licensed technology from an academic institution, recruited a senior management team, advanced the program using contract research organizations (CROs), and raised capital through a grant from the State of Maryland and formed a strategic partnership with an international vaccine company.
Anushri serves as a Principal Consultant at Latham Biopharm supporting clients on integration and management of multiple global vaccine programs against the SARS-CoV2.
Anushri received a Bachelor of Science degree in Botany from the University of Rajasthan (India) and a Master of Science in Environmental Sciences from Rutgers University in New Brunswick, NJ.
J. Chris Detter, Ph.D.
Principal Consultant, Medical Devices and Diagnostics
Dr. Detter is a seasoned molecular and microbiologist that has spent more than 20 years technically and strategically leading highly effective teams in the areas of Global Health, Agriculture Health, and Biosecurity. Chris is a Principal Consultant at Latham BioPharm Group where he provides effective solutions and subject matter expertise to help clients acquire funding, build business, manage contracts, manage programs, and drive innovation.
Previously, Dr. Detter was Chief Scientist at MRIGlobal (CRO) where he provided vision and strategic direction for the Global Health, Surveillance, and Diagnostics Division while leading their Research, Development, Testing and Evaluation (RDT&E) efforts. In this capacity, he led a large, multidisciplinary Scientific Team focused on applied Research & Development for Biothreat and Biodefense mission areas, including high-throughput genomics, global bioengagement, biosurveillance, and diagnostics. A key focus was linking capabilities of industry partners, university collaborators, and other stakeholders to new government funding opportunities and partnerships at DOD, DHS, NASA, CDC, NIH, and BARDA. Prior to his role at MRIGlobal, Chris had an impactful 15yr career at US Department of Energy (DOE) National Laboratories (Lawrence Livermore and Los Alamos) where he spearheaded the R&D efforts of the DOE to sequence and assemble the human genome as part of the Human Genome Program.
Chris has also served as science advisor for US Department of Defense Threat Reduction Agency (DTRA) and on several Science Advisory Boards, Board of Directors for Fortune 500 companies, smaller startups, and US National Laboratories. Chris has scoped, trained, and assisted in setting up genome centers worldwide (including Hawaii, Republic of Georgia, Thailand, Malaysia, and Africa). He has authored more than 100 peer reviewed publications and is the founder and lead organizer for the annual Sequencing, Finishing, and Analysis in the Future (SFAF) Genomic Meeting.
Dr. Detter received his Ph.D. in Molecular Genetics and Microbiology from the University of Florida and his B.S. in Biology from Baylor University.
Cassidy Cantin has worked within the Life Sciences industry for the better part of a decade providing Program Management and Product Leadership with specific experience vaccine and biosimilar development, as well as Business Development and Marketing expertise. As a Consultant for Latham BioPharm Group (LBG), Ms. Cantin will continue to use her knowledge of program management to help clients manage the successful planning and delivery of their government and commercial programs. Her extensive skills in primary and secondary market research and competitive intelligence analysis will assist clients in making strategic decisions and developing their corporate strategy. Prior to LBG, Ms. Cantin was the Senior Manager of Business Development and Marketing at Pfenex Inc., a biologics company focused on biosimilar development. In addition to her business development and marketing responsibilities there, she managed government sponsored programs totaling over $500M and supported a number of successful government proposal efforts.
Ms. Cantin is a certified Program Management Professional (PMP) and holds an MBA from San Diego State University with an emphasis in entrepreneurship and market research. She did her undergraduate work at University of California, San Diego where she earned a B.A. double major in Economics and Public Health. Ms. Cantin was the 2018 President of Women In Bio organization of professionals committed to promoting careers, leadership and entrepreneurship for women in the life science and currently serves on the Board of Directors.
Nikki Nogal, Ph.D.
Dr. Nogal is an experienced Bioengineer with more than 15 years in cell culture research and industry. Throughout her career she has worked at a variety of biotechnology companies including Johnson and Johnson, Gilead and Genentech.
Dr. Nogal is an experienced CMC team leader with technical expertise in biologics process development, manufacturing science and commercial drug substance manufacturing. She has extensive experience in process characterization and process optimization having been lead for several key Mab and recombinant protein vaccine programs. Her responsibilities also included internal/external technology transfer into GMP/commercial manufacturing for production of biotherapeutic proteins and person-in-plant support for upstream campaigns. The scope of her expertise also includes JMP design and analysis of Process Characterization studies. She was also the lead for the analysis and control of post-translational modification of therapeutic proteins. In addition, she also led cell culture medium development and optimization efforts.
Most recently, Dr. Nogal was a Senior Engineer at Genentech where she served as the Technical Lead to improve titers and product quality for one of Genentech’s top tier products. She led upstream operations to optimize commercial scale performance activities for Biologics Drug Substance manufacturing by providing technical oversight for a multi-product, large scale, automated biopharmaceutical facility. She is adept at bringing Quality by Design (QbD) concepts to quality decisions, validation and audit risks. She also provided Drug Substance (Upstream) technical oversight to ensure consistent and continued process performance across the Roche network and played key roles in process improvements and global investigations.
Dr. Nogal graduated with BS and MS degrees in Chemical Engineering from the University of Maryland and her PhD in Biomedical Engineering from Florida State University. She completed postdoctoral training at Johnson & Johnson Pharmaceutical R&D, and University of California San Diego School of Pharmacology and Bioengineering.
Christopher Peterson is a certified PMI project management (PMP) and APICS supply chain (CSCP) project manager with over ten years’ experience in validation, knowledge management, project management, and financial modeling in the Life Sciences industry. As a Senior Consultant with Latham BioPharm Group, Mr. Peterson provides project management services, conducts market research and strategic analysis, and executes financial models in support of company valuations. He brings substantial quality, validation, and documentation management expertise to his clients, including management of their products’ life cycles. His clients include virtual companies through large pharma, and both private and public organizations.
Prior to joining LBG, Mr. Peterson was the business and technical lead at AstraZeneca for the implementation of a data aggregation and analytics software to support commercial process validation. In support of this project, he managed the coordination, configuration, validation, and implementation of the software including selection of the critical process parameters and source data systems, development of bioprocessing hierarchies, and creation of business processes and procedures. Mr. Peterson is also a subject-matter-expert in Microsoft’s SharePoint, administrated a SharePoint-based document management system, and has significant proficiency with multiple Quality Systems and software platforms. Starting his biotechnology career at Merck and Co. as a validation engineer, Mr. Peterson led projects in autoclave load pattern remediation, cleaning and sterilization validation for routine manufacturing, and change management for cleaning and sterilization validation. At Merck, he developed his skills in validation SOP generation, protocol writing, study execution, final report writing and review, and, in a special project, created standardized, CBER-ready protocols and final reports.
Mr. Peterson earned both his Bachelor of Science and Master of Science degrees in Chemical Engineering at Drexel University and is a Project Management Professional (PMP) as certified by the Project Management Institute.
Ms. Speidel has extensive experience in ensuring GxP compliance within both the biologic and pharmaceutical industries, with advanced subject matter expertise within Quality Assurance. As a highly focused Global Quality professional, she is committed to working with development teams to create and maintain the highest possible quality standards. Ms. Speidel brings considerable technical expertise in both biologics and small molecules as well as significant experience with GMP compliance consistent with global regulations and industry expectations.
At Latham BioPharm Group, Inc., she is a Senior Consultant and supports multiple clients to assure their development phase programs meet or exceed industry cGMP requirements by drafting and implementing corporate Quality Management Plans, Quality Manuals, Quality Policy’s, providing audit support by conducting vendor qualification through routine scheduled audits, batch record; review, approval and disposition of lots and labels, deviation and CAPA identification to closures, interpretation and leadership to ICH and international quality standards, and resolution of product quality issues including both drug substance and drug product manufacturing. Notably, she recently crafted a QA package for review by a German QP that received no comments.
Previously, Ms. Speidel served as a QA Supervisor at AstraZeneca. Her responsibilities included supervision, support, lead and direction of the QA Document team at the Frederic site and representation of QA in cross-functional global quality teams. Prior to AstraZeneca she was a production supervisor at the Merck & Co. West Point facility for Pneumovax 23 and Pedvax HIB products. She was also a validation operation scientist conducting field inspections for validated vaccine manufacturing systems for Pneumovax 23, Gardasil HPV, Pedvax HIB, and Multi-drug resistant Staphylococcus Aureus. Ms. Speidel was an Operating Room Nurse at University of Pennsylvania Hospital. She is an Army trained Combat Medic 91B and received the Army Achievement Medal in June 1998 for work instrumental in the accomplishment of the clinical support mission.
Kimberly Weber has more than 17 years of experience leading and performing research in academic and industry laboratories in the areas of immunology, cell biology, molecular biology, virology, microbiology, and assay development and validation, with more than five years of experience in the management of government and commercial contracts. Ms. Weber received her Project Management Professional Certification from the Project Management Institute. She is currently employed by Latham BioPharm Group where she serves as a Consultant providing program management support to government and client-related projects for companies of varying sizes. Ms. Weber previously served as Project/Program Manager for the In Vitro Assay Services Department at Battelle managing highly complex biomedical research programs focused on assay development, diagnostic testing and evaluation, and nonclinical toxicology. Ms. Weber also served as a Research Scientist in the In Vitro Assay Services Department at Battelle where she led development and validation of immunology and molecular-based assays for biothreat, infectious disease, and pharmaceutical products targets. She began at Battelle as an analyst performing high-throughput sample analysis supporting infectious disease vaccine programs.
Ms. Weber began her career studying an in vitro model for Autosomal Dominant Polycystic Kidney Disease and is a graduate of Randolph-Macon College.
Rachel Schmitz, Ph.D.
Dr. Schmitz is a Consultant at LBG, and is actively involved in supporting clients of different sizes and provides programmatic support, as well as helping to manage the successful planning and delivery of government and commercial programs. This includes writing technical weekly, monthly and contractual reports as well as the daily aspects of program support. Dr. Schmitz also provides technical support to programs and reviews new life science products. Additionally, she assists with internal Business Development activities. Dr. Schmitz is a physical chemist with extensive research experience in optical spectroscopy and metal-enhanced fluorescence. Dr. Schmitz’ research experience is focused on the synthesis of fluorescent nanomaterials and the characterization of their optical properties through use of UV-vis spectroscopy, fluorescence and phosphorescence spectroscopy, time-correlated single photon counting (TCSPC), and lasers utilizing ocean optics software. Dr. Schmitz has written and assisted with several peer-reviewed scientific journal articles and presented her research at multiple scientific conferences.
Dr. Schmitz earned her Bachelor of Science in Chemistry at West Virginia Wesleyan College and her Ph.D. in Chemistry at the University of Maryland Baltimore County.
Darrel J. Rezac, Ph.D.
Dr. Rezac is a consultant for both the Nonclinical and Animal Health sectors of Latham BioPharm Group. He provides subject matter and technical expertise, strategic consulting, and business and regulatory team support to a broad portfolio of sponsors, contract research organizations, academic institutions, federal, state, and local government agencies. Dr. Rezac brings in depth knowledge of exploratory and pivotal study design, execution, and management. He applies his unique skill set to administrating programs for bio and agro-defense, nonclinical development and complete regulatory path for veterinary pharmaceuticals and biologics. Previous to his current role, Dr. Rezac held several positions within a US based global contract research organization serving as a Principal Scientist (Clinical Investigator/Study Director), Director of Business Development and Director of Business Operations. In this role he supported and administrated all facets of operations for GLP compliant and AAALAC accredited, high-containment contract research facility and business program. Dr. Rezac guided clients in both pivotal and non-pivotal research enabling the licensure of vaccines, antimicrobials, and insecticides/parasiticides. Dr. Rezac also provided expertise in disease modeling and study design including adherence to GLP (21 CFR Part 58) and GCP (VICH GL9) compliance. Over a 6-year period, Dr. Rezac’s direct research and/or programmatic leadership resulted in over 15 successful product registration submissions with commercial values greater than $500 million. Dr. Rezac is a Captain in the United States Army Reserve Medical Service Corps, the Vice Chair of the Board of Directors of BioKansas and holds appointment as an Adjunct Faculty member in the Department of Diagnostic Medicine/Pathobiology at Kansas State University. He has authored 23 peer-reviewed journal articles or abstracts and routinely delivers invited lectures, media interviews and presentations to key industry decision makers where he is known as a dynamic and energetic communicator and strong leader.
Dr. Rezac received a Ph.D. in Pathobiology, an M.S. in Metabolism/Nutritional Physiology and a B.S. in Animal Science & Industry from Kansas State University.
Consultant, Product Development
As a consultant at LBG, Mr. Williams provides project management and program management support to client-related projects for companies of varying sizes. He is a biopharmaceutical and biotechnology product development professional with more than 10 years of experience, including laboratory benchtop testing, from discovery research to analytical development and post-formulation testing of marketed drugs like Treanda® and Provigil®. Mr. Williams is also a certified lean six sigma black belt (CLSSBB®) and has worked as a process improvement consultant where he helped emerging companies develop and initiate process improvement strategies to minimize waste and make processes more efficient.
Mr. Williams earned both his M.B.A in Strategic Leadership and Management, and B.A. in Biology and Biomedical Sciences from the University of Delaware. He served as a Research Fellow with the Nemours Biomedical Research Institute in Wilmington, DE, where he secured a $2M federal grant from the NIH to perform exploratory research in Neuroscience and Parkinson’s Disease. He was recognized for thought-leadership with several publications in professional peer-reviewed scientific journals related to his research. Mr. Williams also served as a visiting research scholar in the research lab of Dr. David Juncker at the McGill University in Montreal, Canada, where he studied breakthrough technologies in nano-engineering.
Consultant, Product Development
Apurve Dhariwal has significant experience in regulatory affairs working in groups such as strategy, Chemistry Manufacturing and Controls, Quality, and Operations for commercial and development products in the rare and generic drug space. He is experienced in the cross-functional preparation of pre- and post- approval regulatory submissions with a strong understanding of the drug development process and has a firm understanding of health authority regulations. Apurve has successfully contributed to various INDs and BLAs (MAA). He has an extensive knowledge of working with different regulators and has spent time working in quality assurance. The scope of his work has included leading implementation of validated tools, vendor management, audit and inspection. He has worked with biopharmaceutical companies such as Alexion Pharmaceuticals and Genzyme.
Mr. Dhariwal has a Bachelor’s in Pharmacy from Oriental University, India and an M.S. in Regulatory Affairs in Drugs, Biologics and Medical devices from Northeastern University, Boston.
Lauren Schoukroun-Barnes, Ph.D.
Sr. Associate Consultant, Cell and Gene Therapy
Dr. Schoukroun-Barnes is a PMI-certified (PMP) and an APICS-certified (CSCP) project manager. She is an analytical chemist and has extensive research experience in bioanalytical sensor fabrication and utilization, specifically for the detection of small molecule targets directly in biological matrices. Dr. Schoukroun-Barnes started her career as an Analytical Chemist at a small molecule CDMO , where she worked in an FDA and MHRA-regulated cGMP laboratory environment, running validation studies, completing tests for finished drug products (assay, impurity, and preservative methodologies) and samples (stability and release). She is proficient in several laboratory software platforms and analytical and electrochemical methodologies. Dr. Schoukroun-Barnes also has experience at a large molecule CDMO, where she supported the technical submission of proposal responses to RFP requests for non-cGMP and cGMP Drug Substance manufacturing. As such, Dr. Schoukroun-Barnes has extensive experience leading teams that include technical- and business-oriented personnel. Thus, she brings her knowledge to Latham BioPharm Group (LBG) leading and supporting multiple commercial and government programs, their planning and successful delivery. She leads and assists with the management of the day-to-day aspects of projects, and provides technical support, reviews new life science products and technologies, and assists with internal Business Development efforts.
Dr. Schoukroun-Barnes received her Bachelor of Science in Chemistry from Mount St. Mary’s University and her Ph.D. in Analytical Chemistry from the University of Maryland Baltimore County. She has published several peer-reviewed scientific and business geared articles in various journals and presented her research at industry conferences.
Laura Powell, Ph.D.
Dr. Laura Powell contributes to Latham BioPharm’s delivery of client engagements in nondilutive funding and strategic consulting. She leverages her technical expertise and understanding of the government requirements to assist her clients with submitting compliant proposals with robust technical plans. Dr. Powell completed her training in virology and immunology in the Vanderbilt Vaccine Center, under the mentorship of Dr. James Crowe. Her graduate work focused on characterizing the human antibody response, including broadly neutralizing monoclonal antibodies, to arthritogenic alphaviruses with the goal of uncovering protective epitopes and advancing potential therapeutic candidates. Dr. Powell has expertise in managing collaborative projects and has presented her work at several national and international conferences, including Keystone symposia. She is knowledgeable in a wide variety of in vitro assays and techniques. In addition to her bench experience, Dr. Powell has worked as a freelance editor, and has experience writing and editing for both scientific and lay audiences.
Dr. Powell received her Ph.D. in Microbiology and Immunology from Vanderbilt University, and her B.S. in Biological Sciences from the University of Delaware. Her work is published in several peer-reviewed journals.
Associate Consultant, Medical Devices & Diagnostics
Andrew Harmon has over six-years of experience with operations management and logistics, including comprehensive process improvement methodologies supported by a Six Sigma Black Belt certification. Mr. Harmon has a background in biological sciences, with a focus on drug-development and the biomanufacturing process. He has had a wide variety of experience in the field of biotechnology ranging from conducting research in neuro-developmental genetics and mycological lead discovery labs, project and portfolio management, to strategy and business development consulting. His expertise is focused on business strategy, program management and technology commercialization. As an Associate Consultant at LBG, Mr. Harmon supports day-to-day aspects of projects and programs, performs strategic analyses, conducts market research activities, and assists in the technical review of new life science products.
Mr. Harmon earned a Bachelor of Science in Molecular, Cellular & Developmental Biology, an M.M.B. in Microbial Biotechnology and an M.B.A. in Finance and Bioscience Management from North Carolina State University.
Kate Barbour has 5 years research and project management experience in biotech, pharma, and academia; and 3 years’ experience in advertising and business development. She served as Clinical Research Associate at Alliance Foundation Trials working on clinical-stage oncology studies with the Alliance for Clinical Trials in Oncology network at Brigham and Women’s Hospital. Previously, Ms. Barbour was the administrator of ReadCoor, a biotech startup founded at the Wyss Institute by George Church. In graduate school with the Erasmus Mundus program in evolutionary biology (MEME), Ms. Barbour collaborated with a number of universities on research. Ms. Barbour conducted molecular biology thesis research for the University of Groningen on Aquilegia at the Kramer Lab in the Department of Organismic & Evolutionary Biology at Harvard University. With the de Boer lab at Uppsala University and the University of Oslo, she analyzed species of Tanzanian plant medicines with next generation sequencing to aid ecological conservation and public health initiatives. With the de Boer lab, Uppsala University and the National University of Laos, ethnobotanical knowledge of plants was transferred to identify an effective mosquito repellent to prevent malaria and dengue fever. With the University of Montpellier II, she assessed the effects of climate change on Medicago. Before attending graduate school, Ms. Barbour was Director of Sales at a conference organizing company and worked in print advertising sales where she designed outreach solutions for a roster of industry, government, and non-profit clients. She began her career with the French Ministry of Education as an English teacher in high schools.
Ms. Barbour holds a B.S. in Evolutionary Anthropology and a B.A. in French Literature from Douglass College, Rutgers University, an MSc in Biodiversity, Ecology and Evolution from the University of Groningen and an MSc in Ecology and Evolution from the University of Montpellier II. She has conducted genetics research answering questions of evolutionary biology at Harvard University, Uppsala University, the National University of Laos, and the University of Oslo.
Sarah DeDonder, Ph.D.
Dr. DeDonder is a skilled and experienced Quality Assurance professional and analytical scientist. She brings extensive experience in developing, implementing, and maintaining quality management systems to a broad clientele at the Latham BioPharm Group. As an Associate Consultant, she works closely with clients to deliver Quality Management, Continuous Quality Improvement, auditing, knowledge management, and Quality Assurance services to enable successful and compliant GMP and GLP programs.
Dr. DeDonder also brings with her 12 years of regulatory experience from her time with the Kansas Department of Agriculture. In her role as Project Manager, she provided project management support to the Agribusiness Services Division, analyzed federal regulations and rules for their impact to the agency and stakeholders, and served as the scientific liaison between the agency and federal partners. Most recently, Dr. DeDonder served as the Laboratory Program Manager. In this position, she was responsible for the management and oversight of all day to day operations of the laboratory program. She provided both technical guidance and QA oversight to a team of 16 scientists providing regulatory testing while ensuring compliance with ISO/IEC standards. Dr. DeDonder was the project lead for the “concept to completion” planning and oversight of the construction of a brand new, multimillion-dollar state-of-the-art laboratory. During her tenure, Dr. DeDonder was successful in securing new funding to increase the capability and capacity of the laboratory. She authored and was awarded seven grants, totaling $6.65M in federal funding.
Dr. DeDonder earned a B.S. in Biology from Emporia State University, and a M.S. and Ph.D. in Pathobiology from Kansas State University with heavy emphasis on vector borne diseases and food safety and security.
Caty Metcalf has a background in human biology and biosciences management and has been involved in the biotechnology industry for the past six years. Ms. Metcalf has had a wide variety of experience in the field of biotechnology ranging from conducting research in microbiology and neuro-immunology labs, to teaching college-level introductory biology labs, to strategic and business development consulting. Her expertise is focused on technology commercialization. As a Senior Analyst at LBG, Ms. Metcalf supports day-to-day aspects of projects, performs strategic analyses, conducts market research activities, and assists in the technical review of new life science products.
Ms. Metcalf received her Bachelor of Science in Human Biology, Bachelor of Arts in Psychology, and her Master of Microbial Biotechnology degrees from North Carolina State University. She is currently pursuing her Master of Business Administration degree.
Hisham Nachabe has an educational background in biotechnology and molecular biology and has been operating in the field for over 3 years. Prior to graduating, he served as an intern of scientific affairs at Emergent BioSolutions and assisted in day to day aspects of business development and technical diligence. In addition, throughout his career he has occupied a variety of roles within the industry encompassing a wide breadth of laboratory functions. As a Research Fellow with the Integrative Systems Biology group at Fort Detrick, he was responsible for optimizing and executing workflows for miRNA and 16s rDNA sequencing projects. In addition, he is experienced with cell culture and murine training protocols, as well as drafting and editing laboratory Standard Operating Procedures. His functions in the lab covered projects for PTSD, TBI, and the gut microbiome.
Mr. Nachabe received his Bachelor’s of Science in Biology with a concentration in Biotechnology and Molecular Biology from George Mason University.